Post Cond No Reflow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01208727
First received: September 23, 2010
Last updated: May 7, 2013
Last verified: September 2010

September 23, 2010
May 7, 2013
April 2009
April 2009   (final data collection date for primary outcome measure)
Extent of the area of microvascular obstruction [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Extent of the area of microvascular obstruction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group
Same as current
Complete list of historical versions of study NCT01208727 on ClinicalTrials.gov Archive Site
Size of the myocardial infarction [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
Size of the myocardial infarction defined on post-gadolinium CMR images realized 48-72 hours after admission in each group.
Same as current
Not Provided
Not Provided
 
Post Cond No Reflow
The POSTCONDITIONING and THE NO REFLOW Phenomenon in Acute Myocardial Infarction

After having shown that postconditioning allowed a significant 36% reduction of infarct size as assessed by blood levels of myocardial enzymes in acute myocardial patients, the investigators objective is to assess the effect of postconditioning in acute myocardial infarction (AMI) patients on microvascular obstruction lesions defined by cardiac MRI images.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Myocardial Reperfusion Injury
Procedure: postconditioning
Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.
  • No Intervention: Control
    22 controls patients without post conditionment
  • Experimental: Intervention
    22 posconditioned patients
    Intervention: Procedure: postconditioning
Thuny F, Lairez O, Roubille F, Mewton N, Rioufol G, Sportouch C, Sanchez I, Bergerot C, Thibault H, Cung TT, Finet G, Argaud L, Revel D, Derumeaux G, Bonnefoy-Cudraz E, Elbaz M, Piot C, Ovize M, Croisille P. Post-conditioning reduces infarct size and edema in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jun 12;59(24):2175-81.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
March 2011
April 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients > 18 years old,
  • Male or female,
  • Presenting first myocardial infarction, with the beginning of pains < 12 hours,
  • Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on IVA or RCA (not CA).
  • Artery guilty with TIMI flow = 0

Exclusion Criteria:

  • cardiac arrest before the angioplasty,
  • Cardiogenic shock
  • Occlusion of the artery circumflex responsible for the infarction
  • Magnetic resonance imaging: contre indication
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01208727
2008-504
No
Hospices Civils de Lyon
Hospices Civils de Lyon
Not Provided
Study Director: Pierre CROISILLE, MD Hospices Civils de Lyon
Hospices Civils de Lyon
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP